Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product description
MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s:C0392008 C0401692 C0401728 C0392845 C0398970 C0401801 C0402374 C0392845 C0396878 C0391291 C0402620 C0403051 C0396889 C0401679 C0402560 C0394688
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1580-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 16 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Original FDA data
Every field from FDA enforcement report D-1580-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62443
- Address
- 1210 SW 33rd Avenue
- Code information
- Rx #'s:C0392008 C0401692 C0401728 C0392845 C0398970 C0401801 C0402374 C0392845 C0396878 C0391291 C0402620 C0403051 C0396889 C0401679 C0402560 C0394688
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1580-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 16 units
- Termination date
- Aug 15, 2014
- Reason for recall
- Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFERENT PRODUCTS)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall initiation date
- May 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012